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Chlamydia Trachomatis Test Kits

Chlamydia antigen test kit, Chlamydia trachomatis IgG and IgM test kits are rapid test kits, widely used as an aid in the diagnosis of Chlamydia trachomatis infections.

Chlamydia Trachomatis Test Cassette

Intended Use

Chlamydia Trachomatis Swab Antigen Test kit is a rapid test device based on the principle of lateral flow chromatographic immunoassay, and is intended for in vitro diagnostic use in the detection of Chlamydia trachomatis antigen directly from female endo-cervical swab or male urethral swab; Chlamydia Trachomatis IgG and IgM dot assay Kits are rapid test kits based on the principle of dot filtration immunoassay, and are used to detect the IgG and IgM antibody specific to Chlamydia trachomatis antigen in human serum or plasma specimen. All these Chlamydia POCT Test kits are widely used as an aid in the diagnosis of Chlamydia infections.

Early Diagnosis is Important

Although Chlamydia trachomatis infection can be treated and cured with antibiotics, almost no medicine can reverse any damage that the infection has done to the body of the patients before treatment. So, early detection and treatment is of great importance to one's health.

As a result, the Chlamydia trachomatis screening test is of great importance to one's health status, and also helpful to the health condition of partner. And if symptoms such as burning sensation when urinating, or known ever being exposed to the infection of Chlamydia, screening test with a rapid Chlamydia testing kit is recommended, and if positive results appear, visiting a doctor for clinical lab testing is a must. After cured , once a year visit to the doctor is needed, as it is possible to be reinfected with the disease even after treatment.

Chlamydia trachomatis

Chlamydia trachomatis is a human pathogen. Common complications of women infected with Chlamydia include cervicitis, urethritis, endometritis, pelvic inflammatory disease and increased incidence of ectopic pregnancy and infertility, and of men include urethritis and epididymitis. Approximately 70%of women with endo-cervical infections and up to 50% of men with urethral infections are asymptomatic. And as a result, Chlamydia has a nickname of "the Silent Disease".

Chlamydia Trachomatis Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
CHLA 341 Chlamydia AG Swab Test Card Urogenital Swab 20 Bulk: 1000 PCS
Boxed: 32 Boxes
CHLA 3422 Chlamydia Trachomatis IgM Assay serum 25 Bulk: 1200 PCS
Boxed: 36 Boxes
CHLA 3432 Chlamydia Trachomatis IgG Assay serum 25 Bulk: 1200 PCS
Boxed: 36 Boxes
How to Use

Chlamydia AG Swab Test Card

General Information

(IVD Kit »-» Sexually Transmitted Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:CHLA 341
Description:Chlamydia AG Swab Test Card
Category:Sexually Transmitted Disease
Style:Card
Unit:PCS
Specimen:Urogenital Swab
No. of Step:One Step
Reading Time:15 Minutes
Cut Off:10 bacterium/ml
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:97.4%
Specificity:98.7%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:20 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:32 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1000 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):17.5 KG

Materials Provided in the Test Kit

  • Test card in individual foil pouch;
  • Package insert;
  • Disposable urine container (Optional).

Specimen

Female endocervical specimen

Before specimen collection, use a swab or cotton ball to remove excess mucus from the endocervical area and discard.

Use the swab provided along the kit or any shafted swabs with rayon or Dacron tips. The swab should be inserted into the endocervical canal past the squamocolumnar junction, until most of the tip is no longer visible. This will permit acquisition of columnar or cuboidal epithelial cells which are the main reservoir of the organism to detect. Firmly rotate the swab for 15-20 seconds and withdraw without contamination of extra-cervical or vaginal cells.

Alternatively, endocervical specimens can be collected with a cytology brush (Not provided. Caution: do not use cytology brushes with pregnant patients). Insert the cytology brush into the endocervical canal past the squamocolumnar junction. Leave the brush still for two to three seconds. Rotate the cytology brush two full turns, and withdraw the brush without touching any vaginal surface.

Place the swab in the extraction tube, and carry out the test immediately.

Male Urethral specimen

Use standard wire-shafted fiber-tipped swabs for urethral specimen collection. Instruct the patients not to urinate at least one hour prior to specimen collection.

Insert the swab into the urethra about 2-4cm, rotate for 3-5 seconds and withdraw it.

Place the swab to the extraction tube, and carry out the test immediately.

Urogenital Swab Storage Condition

If immediate testing is not possible, the patient sample should be placed in a dry transport tube for storage or transport. The swabs may be stored for 4 hours at room temperature (15-30℃) or 24 hours at refrigerated (2-8℃). Do not freeze.

All specimens should be allowed to reach a room temperature of 15-30℃ before testing.

Testing Principle of Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.

In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.

This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.

When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

Chlamydia Trachomatis IgM Assay

General Information

(IVD Kit »-» Sexually Transmitted Disease -» Dot Immuno Gold Filtration Assay)

Catalog No.:CHLA 3422
Description:Chlamydia Trachomatis IgM Assay
Category:Sexually Transmitted Disease
Style:DOT Card
Unit:PCS
Specimen:serum
No. of Step:Two Step
Reading Time:3 Minutes
Cut Off:
Specification:25T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:DGFIA Capture

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:36 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1200 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):15.0 KG

Materials Provided in the Test Kit

  • Filtration assay device;
  • Washing buffer Gold colloidal Conjugate solution;
  • Disposable dropper for sample transfer;
  • Instruction for use.

Specimen

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

serum Storage Condition

Test specimens as soon as possible after collecting. The specimens can be stored up to 5 days at 2-8°C if not tested immediately. The specimens should be frozen at -20°C for longer time storage. Don’t freeze and thaw the specimens for many times. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing. Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

Testing Principle of DGFIA Capture

DGFIA Capture Method Illustration

For the detection of IgM-class antibodies, capture technique has its advantage in that it can reduce the interference from the IgG class, thus increase the specificity of the test kit.

In a capture dot filtration test kit, antibodies directed to human IgM antibody (anti-i chain) are pre-coated in the test region on the millipore filtering membrane. When specimen is added, the IgM, if present, will be captured by this secondary antibody, anti-IgM.

After washing away the specimen, especially the IgG antibody, the antigen conjugated with colloidal gold particle will be added. If the IgM antibody was captured in the prior step, the IgM will bind to the antigen conjugate. When the colloidal gold particles congregate, a red or pink color will develop, indicating a positive result.

If no IgM in the specimen, this complex will not develop, the antigen conjugated colloidal gold particles will not congregate, and no color will develop in the test region, indicating a negative result.

Information | Packing | Specimen | Principle

Chlamydia Trachomatis IgG Assay

General Information

(IVD Kit »-» Sexually Transmitted Disease -» Dot Immuno Gold Filtration Assay)

Catalog No.:CHLA 3432
Description:Chlamydia Trachomatis IgG Assay
Category:Sexually Transmitted Disease
Style:DOT Card
Unit:PCS
Specimen:serum
No. of Step:Two Step
Reading Time:3 Minutes
Cut Off:
Specification:25T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:DGFIA indirect

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:36 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1200 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):15.0 KG

Materials Provided in the Test Kit

  • Filtration assay device;
  • Washing buffer Gold colloidal Conjugate solution;
  • Disposable dropper for sample transfer;
  • Instruction for use.

Specimen

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

serum Storage Condition

Test specimens as soon as possible after collecting. The specimens can be stored up to 5 days at 2-8°C if not tested immediately. The specimens should be frozen at -20°C for longer time storage. Don’t freeze and thaw the specimens for many times. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing. Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

Testing Principle of DGFIA indirect

DGFIA Indirect Method Illustration

With indirect Dot filtration test kit, the millipore filtering membrane is pre-coated with purified or recombinant viral antigens. The detecting conjugate reagent is stored in a vial, whose main component is rabbit anti human IgG (anti-IgG) antibodies, which is conjugated with colloidal gold particles.

During the first step, sample is added to the sample well in the test cassette. The target IgG antibodies, if present, will be captured by the pre-coated antigens.

The wells are washed to remove unbound serum proteins. Then, the colloidal gold conjugate is added. If the target IgG antibodies have been captured in the first step, the IgG antibody will react with the added secondary antibody, anti-IgG conjugate, and red color will develop, indicating a positive result.

Information | Packing | Specimen | Principle